求人情報

医薬開発本部 クリニカルオペレーションズ（CML） BI20180626-1

掲載開始日 2018.06.26

職種分類

仕事内容

＜Basic Purpose of the job＞
1. To steer the management of the clinical trials from Phase I to Phase IV in Japan according to the clinical development plans in order to obtain regulatory approval in Japan and contribute to international clinical development with the target to optimally address speed, quality, cost, EE involvement and efficiency of preparation, conduct, analysis and reporting of clinical trials (appendix preparation) within the definitions set by legal and regulatory boundaries and ethical standards.
・Act as the main interface between OPU and TCM
・Manage and ensure the assigned clinical trial performance on OPU level
・Take leadership of local trial team
・Ensure inspection readiness activities for the trial on OPU level

2. To contribute to the improvement of internal processes, structures and procedures within ClinOps Japan as well as overall BI Medicine and other functions.
＜Accountabilities ＞
1.
・Execute responsible trial within the agreed timelines
・Establish and ensure subject recruitment with recruitment risk identification and countermeasure setting
・Conduct appropriate site selection and ensure training completion for investigators and site staffs
・Prepare local trial documents and ensure ISF contents
・Lead the local trial team and report progress to relevant stakeholders incl. TCM, local management and cross-functional structure
・Lead data-cleaning activities
・Ensure compliances of CTMS
・Develop and maintain the relationship with investigators, consultants, vendors, contract research organizations
-Establish appropriate subject recruitment plan and identify possible risks and counter measures to achieve the target
- Achievement rate of No of recruited subjects in Japan compare with that in trial total and required rate for committed No in Japan
-Deliverables listed in the Communication Plan for Japan Trial Team
-Minutes for Japan Trial Team Meeting including CRA meeting
-Contribution of PMDA meeting
-Query response after CTN
2
・Execute responsible trial with the expected quality: MVR review, audit report review and action plan, non-compliance CAPA completion
・Oversight and manage required operational activities to ensure high quality of data compliance with SOPs, ICH-GCP/J-GCP and other applicable regulations
・Ensure timely document transfer to TMF
・Ensure inspection readiness activities for the trial on OPU level
-Minutes for Japan Trial Team Meeting including CRA meeting
-Number of Non Compliance reported, rate of major/critical NC, GEM update status
- Audit outcomes, Inspection results
3.
・Prepare local trial budget precisely and get approval by TCM and local management
・Proceed negotiation with study site for milestone payment procedure and FMV principle
・Conduct trial with the agreed budget and update the budget continuously
・Escalate deviation to TCM and local management
-Trial budget deviations, actual per patient cost
-Rate of sites with milestone or visit based payment
-Trial budget deviations, actual per patient cost

4
・Ensure involvement of appropriate external expert sites in responsible trial with close relationship with cross functional team members
-The rate of EE sites in the trial